C P Medical Product is an EO Sterile, Polydioxanone Violet monofilament synthetic absorbable surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Product is sealed inside an inner foil pouch with an outside tyvek pouch. The outer tyvek pouch has the defective seal. No suture is exposed or visible through the foil wrap which must be torn to have access to the suture and needle. Product is boxed (12 to a box) and shrink wrapped. Product is labeled STERILE. Box Label includes: '3/0 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Product is an EO Sterile, Polydioxanone Violet monofilament synthetic absorbable surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Product is sealed inside an inner foil pouch with an outside tyvek pouch. The outer tyvek pouch has the defective seal. No suture is exposed or visible through the foil wrap which must be torn to have access to the suture and needle. Product is boxed (12 to a box) and shrink wrapped. Product is labeled STERILE. Box Label includes: '3/0
Brand
C P Medical
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
CP Medical Product label is coded M398A. Lot number 070122-03 expiration 2010-12. Private distributed label for Webster Veterinary is coded 07-836-4288(M398A). Lot number 070122-03 expiration 2010-12. Private distributed label for Butler is coded 029254. Lot number 070122-03 expiration 2010-12. Private distributed label for Phoenix Pharmaceutical is coded 0398. Lot number 070122-03 expiration 2010-12.
C P Medical is recalling Product is an EO Sterile, Polydioxanone Violet monofilament synthetic absorbable surgical suture wit due to Potential for sterility of product to be compromised. Suture package seals incomplete or missing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for sterility of product to be compromised. Suture package seals incomplete or missing.
Recommended Action
Per FDA guidance
On 04/03/2007 the firm notified its Polyester product (Polybond) customer by telephone and followed up on 04/09/2007 with a letter via certified mail requesting the distributor to discontinue sales of the affected product lot, to notify their customers of the issue, and return stock to CP Medical. The firm provided the distributor with a letter dated 04/09/2007 to be provided to the distributor's customers requested those customers to discontinue use of the affected product lots and return stock to their distributor who in turn are to return product to CP Medical. On 04/20/2007 the firm notified its Polypropylene and Polydioxanone product customers by letter dated 04/17/2007 via certified mail requesting distributors to discontinue sales of the affected product lot, to notify their customers of the issue, and return stock to CP Medical. The firm provided the distributor with a letter dated 04/18/2007 to be provided to the distributor's customers requested those customers to discontinue use of the affected product lots and return stock to their distributor who in turn are to return product to CP Medical.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026